Sr. QA Software Engineer (Temporary)

at  Prismatik

Essential Functions:

• Leads the ongoing implementation of Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal and external/medical device industry best practices.
• Responsible for the administration of the QMS software.
• Conducts investigations and provides corrective and preventive actions based on analysis and review. Provides and implements effective solutions that will drive continuous and measurable improvements.
• Integrates ISO 14971, ISO 13485, risk management and IEC 62366 usability engineering activities with Glidewell/Prismatik processes.
• Fosters and maintains organizational compliance to the quality system including ongoing training and education on software QMS and Prismatik framework.
• Provides CAPA, complaints, audit and overall QMS support in regards to software.
• Performs other related duties and projects as business needs require at direction of management.

Minimum Qualifications:

• Bachelor’s degree in Engineering, Biomedical, or related technical field or equivalent practical experience.
• Minimum of eight (8) years of related experience in the FDA QSR/ISO 13485 medical device industry.
• Advance knowledge with development and test requirements with recognized standards (ISO 13485).
• Demonstrated knowledge of the application of regulatory requirements for wellness, low-risk and high-risk software applications using a scalable approach to the Prismatik practices and the QMS.

Pay range: $95,833-$127,000/yr
Exact compensation may vary based on skills and experience

• Leads the ongoing implementation of Quality Management System (QMS) in conformance with US FDA Quality System Regulations and ISO 13485 Design Controls, through the integration of internal and external/medical device industry best practices.
• Responsible for the administration of the QMS software.
• Conducts investigations and provides corrective and preventive actions based on analysis and review. Provides and implements effective solutions that will drive continuous and measurable improvements.
• Integrates ISO 14971, ISO 13485, risk management and IEC 62366 usability engineering activities with Glidewell/Prismatik processes.
• Fosters and maintains organizational compliance to the quality system including ongoing training and education on software QMS and Prismatik framework.
• Provides CAPA, complaints, audit and overall QMS support in regards to software.
• Performs other related duties and projects as business needs require at direction of management